What's New in Treatment Information?

Peg-Interferon-Alfa Approved for Hepatitis C

The Food and Drug Administration (FDA) recently approved peg-interferon-alfa
(Peg-Intron) for treating hepatitis C virus (HCV). This new formulation
is bound to a chemical called polyethylene glycol, which makes the drug
stay in the blood stream for longer periods than standard interferon-alfa.

The FDA approved using peg-interferon alone and not in combination with
ribavirin (Rebetol). One large study showed that the new formulation was
about twice as effective in controlling HCV replication compared to the
standard formulation (24% vs. 12% of the participants had HCV RNA levels
below 100 copies after 72 weeks). However, more people taking peg-interferon
developed mild bone marrow suppression.

The results of using peg-interferon alone are comparable to those seen
with standard HCV therapy, which is a combination of standard interferon-alfa
and ribavirin (bundled as Rebetron). However, more recent results suggest
that combining peg-interferon with ribavirin will be more effective. Through
injection under the skin, peg-interferon-alfa is dosed only once a week
while standard interferon-alfa is dosed three times a week.

Schering-Plough, the developers of Peg-Intron, recently unbundled
ribavirin from regular interferon, something that the activist community
has demanded for the past two years. So it is now possible for people
to buy ribavirin separately and use it together with other interferon-alfa
products or anti-HCV therapies. The cost of peg-interferon will be about
twice that of standard interferon ($1,200 vs. $600 per month).

Advertisement

Amprenavir Oral Solution Warning

A warning has been issued regarding the use of the oral solution
of amprenavir (Agenerase). This warning does not apply to
the capsule form of the drug.

The oral solution, primarily used with children, may cause more side
effects than the pill form because it contains a large amount of the substance,
propylene glycol. This substance is used to increase the absorption
of the drug.

As a result, amprenavir oral solution should not be used by children
under the age of four, pregnant women, people with liver or kidney failure
and people taking disulfiram (Antabuse) or metronidazole (Flagyl). Additionally,
certain racial groups, Asians, Eskimos and Native Americans, may be more
likely to develop propylene glycol-related side effects because of genetic
differences that impact the way the body breaks down and processes the
chemical. People should also avoid drinking alcohol if they take the oral
solution.

It is unclear, however, whether many adults are using the liquid solution.
People taking amprenavir oral solution should be closely monitored for
propylene glycol-related side effects, including seizures, stupor (mental
numbness), increased heart rate, increased lactate levels (lactic acidosis),
kidney side effects and destruction of red blood cells (hemolysis).

A serious concern about this warning is that it may have the effect of
greatly limiting the use of amprenavir in children. While children can
in theory be switched to the pill form, the currently available pills
are large and difficult to take, even for adults.

HIV-associated Wasting Studies Provide New Results

Recently released results show that adding testosterone to megesterol
acetate (Megace) does not result in additional weight gain. Earlier studies
showed that almost all the weight gained from using Megace is due to fat
gain and not lean body mass gain. Researchers believed this was due to
Megace causing hypogonadism and so reducing the increase in lean
body mass.

In the study, 81 people with HIV-associated wasting disease used either
Megace alone (800mg a day) or together with testosterone (200mg twice
a week for men and 100mg twice a week for women by injection into muscle).
After 12 weeks, people taking Megace alone gained an average of 7.3kg
(about 16 pounds) compared to only 5.3kg (almost 12 pounds) for those
on the combination. Both groups increased their lean body mass by an average
of 3.3kg (about 7 pounds). Not unexpectedly, people taking testosterone
had greater sexual drive and function.

A study of nandrolone (Deca-Durabolin) shows that women taking the drug
had increased weight and lean body mass. The study followed 38 women with
HIV-associated wasting disease. They used 100mg of nandrolone twice a
week by injection into the muscle or placebo for twelve weeks. After the
first twelve weeks, everybody took the drug for another twelve weeks.

Results after twelve weeks showed that women who used nandrolone gained
an average of 4.6kg (about 10 pounds) in weight and 3.5kg (almost 8 pounds)
in lean body mass while those taking the placebo had no significant changes
in either measurement. Some women taking nandrolone experienced virulizing
effects such as hoarseness, excessive hair growth and clitoral enlargement,
though these effects were rare.

ddI Warning

Results from a new study suggest that once a day dosing of ddI may not
be as effective as twice a day dosing. Moreover, the combination of once
a day ddI (400mg) with d4T and nelfinavir (Viracept) was found to be less
effective than AZT + 3TC + nelfinavir. Earlier studies have shown similar
effectiveness between these two combinations when ddI was taken twice
a day.

This new study enrolled 756 people who had not taken anti-HIV therapies
before. Twice as many volunteers used d4T + ddI as those who used received
AZT + 3TC. After 24 weeks, there were no differences between the two groups
and, as a result, the once a day dosing of ddI was approved. However,
after 48 weeks of the study, there was a significant difference in anti-HIV
activity between the two groups. The results after 48 weeks are as follows:

%
<400 copies
HIV RNA

%
<50 copies
HIV RNA

d4T
+ ddI + nelfinavir

53%

41%

AZT
+ 3TC + nelfinavir

62%

51%

As a result of this finding, people are recommended to take ddI twice
a day rather than once a day. There are a couple of possible reasons for
this discrepancy. Twenty-one people (4%) who were supposed to take d4T
+ ddI + nelfinavir did not start therapy compared to five people on 3TC (2%).
Additionally, 20 people (8%) switched from AZT to d4T compared to 16 people
(3%) who switched from d4T to AZT. Most of the AZT to d4T switched occurred
during the first 24 weeks of the study whereas most of the d4T to AZT
switched after the first 24 weeks.

The Body is a service of Remedy Health Media, LLC, 750 3rd Avenue, 6th Floor, New York, NY 10017. The Body and its logos are trademarks of Remedy Health Media, LLC, and its subsidiaries, which owns the copyright of The Body's homepage, topic pages, page designs and HTML code. General Disclaimer: The Body is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through The Body should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.